NCT02151838CompletedNot Applicable
The Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre1 site in 1 country250 target enrollmentStarted: September 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- HIV-infected pregnant women
Study Overview
Brief Summary
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
Detailed Description
- To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
- To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
- To study adverse events in infants born to women who receive HAART during pregnancy
- To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
- To establish the pilot model of care for HIV-infected pregnant women in middle income country
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:
- •HIV-infected pregnant women (as defined by the hospital)
- •Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
- •Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
- •Availability for follow-up for the planned study duration
Exclusion Criteria
- •Volunteers meeting any of the following criteria will be excluded from the study:
- •1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
Outcomes
Primary Outcomes
HIV-infected pregnant women
Time Frame: 18 months
Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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